510(k) · Cleared
ClearedModification to:HL168D Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health & Life Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 22, 2001 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Aug 22, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK012310 Modification to:HL168D Blood Pressure MonitorHealth & Life Co., Ltd. · 2001
- Descendant · cites it directly · 8 of its ownK030230 Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor)Avita Corporation · 2003
- Descendant · 2 generations on · 7 of its ownK110299 Digital Automatic Wrist Blood Pressure Monitor WBPM10 SeriesGrandway Technology (Shenzhen) Limited · 2011
- Descendant · 3 generations on · 6 of its ownK120673 Digital Automatic Wrist Blood Pressure Monitor WBPM15 SeriesGrandway Technology (Shenzhen) Limited · 2013
- Descendant · 4 generations on · 5 of its ownK133618 Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
- Descendant · 5 generations on · 2 of its ownK142088 Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K030230Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor)Avita Corporation · 2003 · cites it directly8descendants
- K110299Digital Automatic Wrist Blood Pressure Monitor WBPM10 SeriesGrandway Technology (Shenzhen) Limited · 2011 · 2 generations on7descendants
- K120673Digital Automatic Wrist Blood Pressure Monitor WBPM15 SeriesGrandway Technology (Shenzhen) Limited · 2013 · 3 generations on6descendants
- K133618Digital Automatic Wrist Blood Pressure Monitor WBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014 · 4 generations on5descendants
- K142088Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SeriesGrandway Technology (Shenzhen) Limited · 2014 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012310 | Modification to:HL168D Blood Pressure Monitor | Health & Life Co., Ltd. | 2001 | — |
| +1 | K030230 | Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor) | Avita Corporation | 2003 | — |
| +2 | K110299 | Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series | Grandway Technology (Shenzhen) Limited | 2011 | — |
| +3 | K120673 | Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series | Grandway Technology (Shenzhen) Limited | 2013 | — |
| +4 | K133618 | Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
| +5 | K142088 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | Grandway Technology (Shenzhen) Limited | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030230 | Avita BPM1 Series (Wrist Type) Blood Pressure Meter (or Monitor) | 2003 | 8 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030230 (Avita Corporation, 2003) has gone furthest, with 8 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
Measures automatically human’s Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.
The intended for use of this over-the-counter device is for age 16 and above.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012310 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012310: Modification to:HL168D Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012310
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026